2020 Chemicals Workshop Webinar Series TSCA 4.0: Now What? Steve - PowerPoint PPT Presentation

2020 Chemicals Workshop Webinar Series TSCA 4.0: Now What? Steve Owens and Allen Kacenjar Wednesday, August 5

Welcome Karen Winters Environmental, Safety & Health Practice Group Leader, Columbus T +1 614 365 2750 E karen.winters@squirepb.com Jennifer Klein President, Ohio Chemistry Technology Council, Columbus T +1 614 224-1730 E jklein@ohiochemistry.org Stephen Owens Partner, Phoenix and Washington DC T +1 602 528 4170 E steve.owens@squirepb.com Allen Kacenjar Jr. Partner, Cleveland T +1 216 479 8296 E allen.kacenjar@squirepb.com squirepattonboggs.com 2

2016 TSCA Amendments  Lautenberg Chemical Safety Act signed into law on June 22, 2016.  Requires EPA to evaluate new and existing chemical substances to determine whether they present an unreasonable risk of injury to health or the environment under the conditions of use.  Prohibits consideration of costs or other non-risks factors in evaluations.  Requires EPA to consider potentially exposed or susceptible subpopulations in evaluating chemical substances.  Authorizes EPA to issue administrative orders to require testing of chemicals.  Eliminates the “least burdensome” requirement for chemical restrictions.  Allows EPA to charge new/higher fees for chemical reviews.  Preempts state chemical regulations under certain conditions. squirepattonboggs.com 3

What’s Up with the “First 10” TSCA Risk Evaluations?  On December 19, 2016 EPA initiated risk evaluations on 10 substances:  Asbestos; 1-Bromopropane; Carbon Tetrachloride; 1,4 Dioxane; Cyclic Aliphatic Bromide Cluster (HBCD); Methylene Chloride (MC); N-Methylpyrolidone (NMP); Perchloroethylene; Pigment Violet 29 (PV29); Trichloroethylene (TCE).  TSCA imposes a 3-year deadline on EPA to complete a risk evaluation.  But gives EPA the ability to extend the deadline for up to 6 months  EPA missed the December 2019 deadline for all the risk evaluations.  EPA missed the extended June 2020 deadline for 9 of the 10 risk evaluations.  EPA issued only one final risk evaluation by the June deadline.  Methylene Chloride (MC) – completed on June 19.  NGOs have filed a lawsuit challenging EPA’s “no unreasonable risk” determination for several uses of MC.  No timeline for when EPA will finalize the remaining 9 risk evaluations. squirepattonboggs.com 4

What’s Causing the Delay?  Drafts for some risk evaluations were issued very late.  Especially asbestos and perchloroethylene.  Delayed public comments and peer review by the TSCA SACC.  Extensive substantive comments on some risk evaluations.  EPA has received criticism from the SACC and the NAS – as well as NGOs and industry groups -- for its “systematic review” process.  The SACC also criticized EPA’s lack of data and assumptions in some risk evaluations.  EPA has to consider legacy uses due the 9 th Circuit ruling in Nov. 2019.  EPA recently said that it will address legacy uses in the HBCD risk evaluation.  For asbestos, EPA plans to issue “a supplemental scope document and supplemental risk evaluation” to address legacy uses and associated disposal.  EPA recently received data on PV29 in response to the TSCA §4 testing order that EPA issued in March 2020.  EPA recently received several NMP studies. squirepattonboggs.com 5

What Happens When Risk Evaluations Are Late?  Preemption  “Pause preemption” does not apply to the first 10 risk evaluations. • Under TSCA §16, for the next risk evaluations, preemption will begins on the date that the risk evaluation scope is defined and ends “on the date on which the deadline … for completion of the risk evaluation expires , or on the date on which the Administrator publishes the risk evaluation …, whichever is earlier .”  For first 10, preemption applies only when EPA issues final TSCA §6 risk management rule.  But the delay of a final risk evaluations means a delay in the final §6 rule, which gives states more time to act (and also cuts into EPA’s time to issue the §6 rule).  Delay in risk evaluations may be (indirectly) delaying the final scope documents for the next 20 risk evaluations.  Which also delays pause preemption for these substances.  Delay is creating uncertainties, including what happens if EPA leadership changes after upcoming election.  Rulemakings, risk evaluations and outcomes of lawsuits could be determined by new officials. squirepattonboggs.com 6

What Issues Have Been Raised Regarding the Risk Evaluations?  EPA’s exclusion of uses in the risk evaluations.  Exclusion of legacy uses and associated disposal.  Exclusion of uses regulated by EPA under other statutes.  Exclusion of some subpopulations.  Assumptions about exposures and hazards.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260 (9 th Cir. Nov. 14, 2019)  Ruled that EPA must consider legacy uses and associated disposal of substances.  Can be read to say that while EPA has discretion to determine the conditions of use for a substance, EPA cannot exclude those uses once they have been determined.  “If EPA does, in the future, fail to consider all conditions of use together in completing a risk evaluation, and if Petitioners are harmed by that failure, then Petitioners may, under TSCA, seek review of EPA’s “no unreasonable risk” determination .”  NGOs and labor groups have filed a petition challenging the methylene chloride risk evaluation.  Neighbors for Environmental Justice v. EPA , No. 20-72091 (July 16, 2020). squirepattonboggs.com 7

What Happens Next After a Risk Evaluation is Finalized?  Determination of Unreasonable Risk  If EPA determines that any use of a substance presents an unreasonable risk of injury to health or the environment, the agency must “immediately” begin to develop a risk management rule under TSCA §6 to address the risk(s).  Determination is not a “final agency action”; only the TSCA §6 rule is appealable.  EPA could impose a range of requirements and restrictions, including an outright ban on some (or all) of the uses.  EPA must issue a proposed TSCA §6 rule within one year after the final risk evaluation is issued.  The final §6 rule must be issued within 2 years after the final risk evaluation is issued.  EPA may extend the deadline by 2 years. • But extensions for risk evaluations count against this.  Determination of No Unreasonable Risk  A “no unreasonable risk” determination must be made by an order.  The order is a final agency action that is judicially reviewable. squirepattonboggs.com 8

Neighbors for Environmental Justice, et al. v. EPA Who: Unions and environmental NGOs, including Sierra Club and NRDC. Where: The United States Court of Appeals for the Ninth Circuit When: Filed on July 16, 2020 What:  EPA issued its (753-page!) final risk evaluation for methylene chloride on June 19, 2020 – the first under the amended TSCA.  EPA determined that 47 commercial, industrial and consumer uses posed “unreasonable risk” and 6 uses did not.  The unreasonable risk findings trigger EPA’s statutory duty to establish risk management measures for those 47 uses.  Petitioners’ notice generally challenges EPA’s determination that “ methylene chloride does not present an unreasonable risk of injury to health or the environment under certain conditions.” It also contends that EPA “ declin[ed] to consider certain uses and pathways” that create exposure s/risks. squirepattonboggs.com 9

Threshold Question – Ripeness & Scope  Is what EPA did “final agency action” subject to judicial review?  TSCA provides that a determination “that a chemical substance does not present an unreasonable risk of injury to health or the environment shall be issued by order and considered to be a final agency action . . .”. 15 U.S.C. § 2605(i)(1).  In the final risk evaluation, EPA recognizes that its six “no unreasonable risk” determinations… are considered to be final agency action effective on the date of issuance of this order.”  According to EPA, the unreasonable risk determinations for the remaining 47 uses “are not considered final agency action” under TSCA §6(i)(2). squirepattonboggs.com 10